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C.E.R.A. Corrects Anemia in Patients with Chronic Kidney Disease not on Dialysis

2008; Lippincott Williams & Wilkins; Volume: 3; Issue: 2 Linguagem: Inglês

10.2215/cjn.00480107

1555-905X

Iain C. Macdougall, Rowan G. Walker, Robert Provenzano, Fernando de Álvaro, Harold Locay, Paul C. Nader, Francesco Locatelli, Frank C. Dougherty, Ulrich Beyer, Paolo Altieri, Marcello Amato, Magnus Annerstedt, Anna Balducci, Philippe Barré, C. Breen, Elizabeth E. Brown, Rafael Burgos-Calderón, G. Carpenito, Gabriel Choukroun, Lourdes Craver, Bruce F. Culleton, Fernando de Álvaro, Giacomo Deferrari, M. del Pino y Pino, G. P. Dragoun, D Durand, Vincent Esnault, P. Evenepoel, B Faller, A. Fine, Doron Fischer, Marco Formica, Ulrich Frei, Leon Frenken, Thomas A. Golper, Claus Hagen, Kai Hahn, Kevin Harris, E Imbasciati, Cyril Jacquot, Shruti Jolly, George A. Kaysen, Peter G. Kerr, M. Kessler, Nelson Kopyt, Csaba P. Kövesdy, Jeffrey A. Kraut, John Kwan, Richard A. Lafayette, Martine Laville, Adeera Levin, Francesco Locatelli, Harold Locay, Charmaine E. Lok, Iain C. Macdougall, Iain MacPhee, Jorge Franco, Alberto Martínez Castelao, Alan W. McMahon, Enrique Morales, Nicola Muirhead, S. Murphy, Paul C. Nader, George M. Nassar, Sadie A. Noble, Georgios Papadakis, Ioannis Papadakis, Jeffrey G. Penfield, Vincent Pichette, Robert Provenzano, George Pylypchuk, T. Risler, Diego Rodrı́guez-Puyol, Steven J. Rosansky, Garifallia Sakellariou, Rebecca J. Schmidt, Kostas C. Siamopoulos, Richard Solomon, Bruce Spinowitz, Bernd Stegmayr, Michael Suranyi, Pkh Tam, Sheldon W. Tobe, Vasilios Vargemezis, C. Vela, Giuseppe Villa, Rowan G. Walker, Kevin Warr, C.R. Wijeyesinghe, Rainer P. Woitas, Carmine Zoccali,

Iron Metabolism and Disorders

This study examined the efficacy of C.E.R.A., a continuous erythropoietin receptor activator, for correcting anemia in patients who had chronic kidney disease (CKD) and were not on dialysis.In this open-label, randomized, parallel-group, Phase III study, 324 adult patients with CKD not on dialysis nor receiving treatment with erythropoiesis-stimulating agents (ESAs) were randomly assigned (1:1) to receive subcutaneous C.E.R.A. once every 2 wk or darbepoetin alfa once weekly during an 18-wk correction period and a 10-wk evaluation period. Thereafter, patients receiving C.E.R.A. were randomly assigned to C.E.R.A. once every 2 wk or once monthly, and patients receiving darbepoetin alfa could receive darbepoetin alfa once weekly or once every 2 wk for a 24-wk extension period. Dosage was adjusted to achieve a hemoglobin (Hb) response and to maintain Hb +/-1 g/dl of the response level and 11 to 13 g/dl. Primary end points were Hb response rate during correction and evaluation and change in Hb concentration between baseline and evaluation.Hb response rates were 97.5% for C.E.R.A. and 96.3% for darbepoetin alfa. Adjusted mean changes in Hb from baseline to evaluation were 2.15 g/dl (C.E.R.A.) and 2.00 g/dl (darbepoetin alfa). Analysis showed that C.E.R.A. once every 2 wk was as effective as darbepoetin alfa once weekly for correcting anemia. Hb levels remained stable in all groups during the extension period. C.E.R.A. and darbepoetin alfa were well tolerated.Subcutaneous C.E.R.A. once every 2 wk corrects anemia in ESA-naïve patients who are not on dialysis.